KEY RESPONSIBILITIES

RA: Product registration

• Conduct timeous compilation of due diligence on new dossier and communicates findings to Lupin or Third-Party Supplier as required
•  Compile and submit any TB and/or ARV dossiers to regulatory authorities in eCTD at agreed timelines
• Liaise with regulatory authorities on New Dossiers, SAHPRA queries and variations when required
• Ensure that Site Master Files are submitted to regulatory authorities for Overseas Third Party Supplier)
• Conduct due diligence on variations received from Third Party Suppliers or internal requirements
• Ensure any variations are logged on the CCP register and managed until completion
• Compile and submit all responses to regulatory authorities queries, Safety Updates and variations, within agreed and specified time limits.
• Manage the GMP compliance of API’s and manufacturers on an ongoing basis and ensure any deviations or potential quality risks are communicated to the Responsible Pharmacist
• Maintain the department’s online apps (CCP database, docuBridge, Artwork app) as per official SOPs and/or working instructions.
• Ensure all dossier related procedures, templates and quality standards are adhered to
• Ensure all correspondence and or dossier information is filed appropriately
• Maintain an accurate product history and ensure the electronic database for regulatory dossiers are current and accurate
• Review product artwork and ensures compliance with registration and labelling regulations of Medicines and Related Substances Act 101 of 1965, in line with tender requirement.
• Interact with Lupin and Third-Party Suppliers on dossier related activities (supplier meetings)
• Provide regulatory advice to internal and external stakeholders when required.

QA: Product realization & Lifecycle activities:

• Ensure that timelines related to launch processes and product lifecycle maintenance are adhered to and that formal processes exist to govern product realization.
• Oversee and execute quality assurance operations for the preparation and release of products.
• Oversee and coordinate Lot Release preparations for products, ensuring compliance with GMP, the registered dossier and prescribed procedures.
• Ensure that laboratory consumables are effectively procured and managed thereby ensuring timelines are met for any testing activities.
• Compilation, conducting periodic updates and completion of Technical Quality Agreements related to product realization, if required.
• Co-ordinating and conducting the Product Quality Reviews to assess the ongoing effectiveness of quality systems of newly launched products.
• Manage Analytical Method Transfer and Stability processes to ensure accurate and reliable testing.
• Conduct risk assessments and develop mitigation strategies where required.
• Coordinate activities involved with product realization and product reworks, if required.
• Ensure technical transfers or validation activities are performed as per the functions stipulated for the project team. Ensure timelines are strictly adhered to.
• Assist with the compilation and/or review of departmental QMS documentation.
• Ensure destructions are recorded and managed effectively when required.
• Ensure that good documentation practices are always adhered to and that data integrity is maintained.
• Conduct supplier audits to ensure compliance and quality of incoming products.
• Initiate Issue Logs and drive investigations to track and address quality-related concerns promptly.
• Ensure correspondence with authorities is handled (e.g. for permits, etc.) is handled effectively and timeously.
• Oversee and coordinate Lot Release preparations for launch batches, ensuring compliance with GMP, the registered dossier and prescribed procedures.
• Attend and/or present training sessions as and when required.
• Liaise with 3rd parties and internal stakeholders to ensure product realization is effectively coordinated.
• Ensure stakeholder reporting is performed as and when the need arises.
• Ensure that master data is maintained and kept up to date.
• Actively seek and implement continuous improvement activities to ensure that reporting team maintains a competitive industry advantage.
• Coordinate and/or prepare applications for PIT exemption for submission to SAHPRA.
• Ensure that master data is maintained and kept up to date.
• Perform any other duties as per operational requirements of the department.

Good Manufacturing Practice

• Maintain all GMP principles in line with departmental Quality Management System and SAHPRA/PICs GMP requirements.

General

• Perform any other duties as per changes in operational requirements of the department.
• Ensuring goals and objectives of direct report align with GIB departmental strategies.
• Assist with Product Development and Product Technical Transfer projects.

Requirements

PRE-REQUISITES

• B.Sc. degree or equivalent scientific qualification.
• Minimum of 1-2 years Regulatory hands-on experience, preferably within the pharmaceutical industry.
• Proven experience in quality assurance within the pharmaceutical industry, with a focus on new product launches (advantageous).
• Detail-oriented with strong analytical and problem-solving abilities.
• Demonstrated ability to drive continuous improvement and implement best practices in quality assurance.
• Strong knowledge of regulatory requirements, including SAHPRA, Africa and international guidelines.
• Able to perform all standard registration processes under specialist guidance.
• Experience in other areas of pharmaceutical industry such as production and/or analytical environment would be advantageous